Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption

Exclusion Criteria

• •1. Presence of abnormalities of the lumbar spine that would prohibit assessment of lumbar spine BMD, defined as having at least 2 radiologically evaluable vertebrae within L1-L4.
• •2. Unevaluable hip BMD or participants who have undergone bilateral hip replacement (unilateral hip replacement is acceptable).
• •3. History of bone disorders (for example, Paget's disease) other than postmenopausal osteoporosis.
• •4. Clinically significant abnormality of serum hemoglobin, hematocrit, white blood cells (WBC) and platelets, coagulation, or usual serum chemistry: electrolytes, renal function, liver function and serum proteins.
• •5. Unexplained elevation of serum alkaline phosphatase.
• •6. History of radiotherapy (radiation therapy), other than radioiodine.
• •7. History of bleeding disorder that would preclude a bone biopsy, in the opinion of the Investigator.
• •8. History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances to a degree that would interfere with the interpretation of study data or compromise the safety of the participant.
• •9. History of Cushing's disease, hyperthyroidism, hypo- or hyperparathyroidism, or malabsorptive syndromes within the past year.
• •10. History of significantly impaired renal function (serum creatinine \> 177 micromoles \[µmol\]/L or \>2.0 milligrams \[mg\]/deciliter \[dL\]). If the serum creatinine is \>1.5 and ≤ 2.0 mg/dL, the calculated creatinine clearance (Cockcroft-Gault) must be ≥ 30 mL/minute (min).
• •11. History of any cancer within the past 5 years (other than basal cell or squamous cell cancer of the skin).
• •12. History of osteosarcoma at any time or a history of hereditary disorders which could predispose the participant to osteosarcoma.
• •13. History of nephrolithiasis or urolithiasis within the past 5 years.
• •14. Participant known to be positive for hepatitis B, hepatitis C, or human immunodeficiency virus infection (HIV-1 or HIV-2). Testing is not required in the absence of clinical signs and symptoms suggestive of HIV infection or acute or chronic hepatitis.